Optimasi dan Validasi Metode Penetapan Kadar Obat Antibiotik Sefiksim berdasarkan Farmakope Indonesia Edisi VI.

Abstract

CHINDAGA AZZAHRA SURACHMAN. Optimasi dan Validasi Metode Penetapan Kadar Obat Antibiotik Sefiksim berdasarkan Farmakope Indonesia Edisi VI. Dibimbing Oleh TRIVADILA Sefiksim merupakan antibiotik golongan sefalosporin generasi ketiga yang memerlukan metode analisis yang valid untuk menjamin mutu sediaan farmasi. Penelitian ini bertujuan mengoptimasi dan memvalidasi metode penetapan kadar sefiksim menggunakan Kromatografi Cair Kinerja Tinggi (KCKT) berdasarkan Farmakope Indonesia Edisi VI. Optimasi dilakukan melalui variasi laju alir fase gerak 0,8; 0,9; dan 1,0 mL/menit. Kondisi optimum diperoleh pada laju alir 0,9 mL/menit dengan parameter kesesuaian sistem yang memenuhi persyaratan. Validasi metode meliputi spesifisitas, akurasi, presisi, linearitas, selektivitas, dan robustness sesuai pedoman ICH Q2(R2). Hasil validasi menunjukkan tidak terdapat interferensi dari pelarut, nilai recovery memenuhi rentang 98–102%, nilai %RSD kurang dari 2,0%, hubungan konsentrasi dan respon bersifat linear, serta metode tetap memenuhi persyaratan pada variasi laju alir. Metode penetapan kadar sefiksim menggunakan KCKT dinyatakan valid dan layak digunakan untuk analisis rutin.

CHINDAGA AZZAHRA SURACHMAN. Optimization and Validation of an Analytical Method for the Determination of Cefixime Content According to the Indonesian Pharmacopoeia, Sixth Edition. Supervised by TRIVADILA. Cefixime is a third-generation cephalosporin antibiotic that requires a valid analytical method to ensure pharmaceutical product quality. This study aimed to optimize and validate a cefixime assay method using High Performance Liquid Chromatography (HPLC) based on the Indonesian Pharmacopoeia Sixth Edition. Optimization was carried out by varying the mobile phase flow rate at 0.8, 0.9, and 1.0 mL/min. The optimum condition was obtained at a flow rate of 0.9 mL/min with acceptable system suitability parameters. Method validation included specificity, accuracy, precision, linearity, selectivity, and robustness according to the ICH Q2(R2) guideline. The results showed no pelarut interference, recovery values within 98–102%, %RSD values below 2.0%, a linear relationship between concentration and detector response, and acceptable performance under flow rate variations. The HPLC method was considered valid and suitable for routine cefixime analysis.